INFORMED PATIENT CONSENT FOR SURGICAL OPERATION, MEDICAL PROCEDURES AND/ OR TREATMENT ACKNOWLEDGEMENT OF RECEIPT OF MEDICAL INFORMATION Material Risks Identified by Physician – Daniel R. Yanicko, Jr., M.D. INFORMATION ABOUT THIS DOCUMENT – READ CAREFULLY BEFORE SIGNING TO THE PATIENT: You have been told that you should consider medical treatment/surgery. This document will outline for you (1) the nature of your condition, (2) the general nature of the medical treatment/surgery, (3) the most common risks of the proposed treatment/surgery, as determined by your doctor, (4) reasonable therapeutic alternatives and material risks associated with such alternatives, and (5) risks of no treatment. You have the right, as a patient, to be informed of your condition and the recommended surgical, medical, or diagnostic procedure to be used so that you make the decision whether or not to undergo the procedure after knowing the risks and hazards involved. In keeping with the Informed Consent recommendations, you are being asked to sign a confirmation that we have discussed all these matters. Please read the form completely. As we have already discussed the common problems and risks with you, we wish to inform you as completely as possible about your medical treatment/surgery. Ask questions about anything you do not understand about, and we will be pleased to explain further. PATIENT NAME: _________________________________ DIAGNOSIS/IMPRESSION: ________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ SURGICAL PROCEDURE (S): ______________________________________________ ____________________________________________________________________ ____________________________________________________________________ ____________________________________________________________________ ____________________________________________________________________ ____________________________________________________________________ REASONABLE THERAPUETIC ALTERNATIVES TO SURGERY: Surgical and nonsurgical options have been discussed with the patient, and questions were answered for the relative advantages and disadvantages of the recommended operation/medical treatment, including risks of no treatment or surgery for this condition. FURTHERMORE, I understand there are risks in this Operation/Treatment/Special Procedure, but I DO NOT wish to know all the details and trust the Doctor’s professional ability to carry out the PROPOSED SURGICAL TREATMENT PLAN and/or medical treatment care as deemed appropriate and necessary for my ultimate benefit. INFORMED CONSENT – Daniel R. Yanicko, Jr., M.D. Page 2 Material Risks: All medical or surgical treatment involves risks. Listed on the next few pages are those risks associated with this procedure that we believe a reasonable person in your (the patient’s) position would likely consider significant when deciding whether to have or forego the proposed treatment. Please ask your physician if you would like additional information regarding the nature or consequences, the likelihood of occurrence, or other associated risks that you might consider significant but may not be listed in this document. MUSCULOSKELETAL TREATMENTS AND PROCEDURES A surgical procedure upon, or even a closed manipulation of an extremity, entails risk to a greater or lesser degree, to all major systems of that limb, and can result in varying degrees of weakness, deformity, bleeding, infection, disfiguring scars, paralysis (loss of function), pain, numbness, amputation, and/or limitation of joint range of motion. Anesthesia complications can include heart attack, stroke, brain damage, pneumonia, and death. Furthermore, the goals/expected outcome of the procedure may not be obtained and other medical therapy/surgical treatments may become necessary to achieve the goals of the original operation. COMPLICATION LIST FOR ALL ORTHOPEDIC SURGICAL PROCEDURES: Uncommon Risks --severe bleeding that requires blood transfusion; scars-sometimes overly thickened to keloid formation; infection; continued or worsened pain/stiffness or deformity; failure of tissue/bone healing; hardware/prosthesis implant failure and need for early removal or revision; blood clots to legs (phlebitis) deep vein thrombosis and /or blood clots to lungs (pulmonary embolus). Very Uncommon Risks --artery, vein, nerve, or tendon damage; amputation; paralysis or loss of limb/ joint function; need for later implant removal, with or without revision. ADDITIONAL SPECIFIC RISKS FOR VARIOUS ORTHOPEDIC PROCEDURES: o FRACTURE REPAIR: OPEN REDUCTION and INTERNAL FIXATION by METAL PLATES, SCREWS, WIRE CABLES, PINS and/ or IM RODS – Uncommon Risks -Metal fatigue/breakage with the need for later removal; Failure of bone healing (nonunion) or delayed union; Improper bone healing with shortening or angular deformity (malunion); Loss of motion, joint stiffness, growth plate malfunction or joint arthritis; and Pain due to extra bone, cartilage damage, and/or scar formation. o OPERATIVE ARTHROSCOPY OF JOINTS / ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION -- KNEE – Common Risks -- Postoperative swelling / bleeding. Uncommon Risks -- Scar formation with loss of motion; Cartilage damage and/or progression of arthritis; Graft failure or rejection. o TOTAL KNEE REPLACEMENT – Common Risks -- Permanent lateral knee skin sensory loss – lateral branch of the saphenous nerve. Uncommon Risks -- Limitation of motion and pain due to extra bone formation/ scar. Very Uncommon Risks -- Bone fracture-femur, tibia, or patella (kneecap); Ligament damage; Loosening or dislocation of knee/prosthetic parts; Rupture/ tear of patellar/quadriceps tendon(s) or collateral ligaments. INFORMED CONSENT – Daniel R. Yanicko, Jr., M.D. Page 3 o TOTAL HIP REPLACEMENT/BIPOLAR HEMIARTHROPLASTY – Uncommon Risks -- Limitation of motion due to extra bone formation or scar; Leg length inequality or change; Groin and/or thigh pain; Bone fracture – femur or pelvis; Loosening and/ or dislocation of hip/ prosthetic parts; Nerve and/or artery injuries that impair function. o JOINT FUSION -- An operation to remove the damaged arthritic and/or infected joint by healing the bones involved together to produce permanent loss of joint motion. Uncommon Risks -- Deformity; Failure to heal properly-malunion or nonunion; Need for later hardware removal; Residual pain at the fusion site or other nearby joints. o SHOULDER SURGERY: ACROMIOPLASTY, BICEPS TENDON and LABRAL / CAPSULE / ROTATOR CUFF REPAIR, and TOTAL / REVERSE / PARTIAL SHOULDER REPLACEMENT – Uncommon Risks -- Recurrent tear of the repaired tendon and/or instability or joint dislocation; Arthritis; Loss of motion due to scarring; Loosening, malposition and/or dislocation of prosthetic parts. o HAND SURGERY: CARPAL TUNNEL RELEASE; ULNAR NERVE TRANSPOSITION; THUMB 1st CARPOMETACARPAL JOINT TENDON INTERPOSITION ARTHROPLASTY; TENDON/ NERVE/MUSCLE REPAIR; SYNOVECTOMY or TENDON SHEATH RELEASE, TENDON TRANSFER (S), TUMOR REMOVAL; JOINT RECONSTRUCTION or FUSION – Uncommon Risks -Incomplete return of hand function, sensation, and/or grip strength; Arthritis; Failure to relieve numbness/pain; Scarring of tendon or nerve that prevents normal motion and function; Recurrent rupture of tendon/muscle; Swelling/pain at incision site and entire hand/finger; Loosening of joint or malposition, deformity, or loss of motion. o ANKLE/ FOOT SURGERY: TENDON TRANSFER, OSTEOTOMY and/or JOINT FUSION; ANKLE LIGAMENT RECONSTRUCTION; ANKLE/SUBTALAR JOINT FUSION or TRIPLE ARTHRODESIS; BUNIONECTOMY; HAMMER/CLAW/MALLET TOE REPAIRS; CYST/TUMOR REMOVAL; PLANTAR FASCIA RELEASE – Uncommon Risks -- Loss of motion; return of cyst/tumor; incomplete fusion or loosening of joint parts; need for later implant or metal removal. ACKNOWLEDGEMENT – AUTHORIZATION AND CONSENT Dr. Yanicko has discussed this material with me. All information given me, and, in particular, all estimates made as to the prospects of success or the likelihood of occurrence of risks of this medical treatment, surgery, or alternative procedure, are made in the best professional judgment of my physician. Further, I understand that no guarantees about any surgery and/or medical treatment outcome can be given to me. As such, I impose no specific limitation(s) to my care by the Doctor unless written here________________________________________________________ _______________________________________________________________________________ The nature and possibility of complications cannot always be accurately anticipated. Therefore, there is and can be no guarantee (either expressed or implied) as to the ultimate success and results of the medical treatment or surgical procedure(s). Nothing further has been said to me; no other informational materials have been given to me; and I have not relied upon any other information that is inconsistent with or contrary to the written explanations set forth in this document. INFORMED CONSENT – Daniel R. Yanicko, Jr., M.D. Page 4 Consent: I hereby authorize, consent thereto and direct Daniel R. Yanicko, Jr., M.D., together with associates and/or assistants of his choice, to administer or perform the above-listed medical treatment/surgical procedure described in this Consent form; including any additional procedures or services as they may deem necessary or reasonable. This includes: if needed, administration of general or regional anesthesia by or under the direction and supervision of a member of the Department of Anesthesia; the administration of local anesthesia or conscious sedation by the Doctor performing my procedure; administration of x-rays or other radiologic services; laboratory services; insertion of bone graft substitutes or calcium bone void fillers; and the disposal, examination, or preservation for study of any tissue removed during the surgical procedure(s). ___ Blood transfusion is not generally needed with this procedure. ___ If needed, I consent to the use of blood and /or blood products, as deemed necessary. Specific risks associated with transfusion include: fever, rash, heart failure, acute/chronic liver inflammation/viral infection called Hepatitis B/C that can lead to scarring and/or cirrhosis, other blood infections, AIDS (acquired immune deficiency syndrome), and/or transfusion reactions that may cause kidney failure, anaphylactic shock, anemia or death. Furthermore, I understand the material as presented above, and I have reviewed all information presented in this document and hereby acknowledge that I have had the opportunity to ask any questions about the contemplated medical treatment/surgical procedure (including risks, benefits, complications, and alternatives), and state that any and all of my questions have been answered to my complete satisfaction. I have read and understand all information set forth in this document, and all blanks were filled in prior to my signature. Signature of Patient or Authorized Person: ________________________________________ Printed Name: ___________________________________ Date/Time: ____________________ ____If patient is a minor or unable to consent -- list age and/or reasons and list relationship. Witness Certification: The patient was informed and appears to understand all material covered in this Informed Consent document, and signed this form on the indicated date and time noted. Signature of Witness: _____________________________ Date/Time: _____________________ Printed Name: _______________________________ Physician Certification: I hereby certify that I have provided and explained the information set forth, herein, and answered all questions of the patient, family members and / or the patient’s authorized person, concerning the medical treatment or surgical procedure(s), to the best of my knowledge and ability as a Board-certified Orthopaedic Surgeon. Signature of Physician: ________________________________Date/Time: _________________ Daniel R. Yanicko, Jr., M.D. ____ To help me understand and consent for my operation, medical treatment, and/or procedure -this form has been translated into _______________ by __________________________